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Monoclonal Antibodies

CABA-201 for Inflammatory Myopathies

Phase 1 & 2

Recruiting

Research Sponsored by Cabaletta Bio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of muscle weakness

Age ≥18 and ≤65

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28 days after caba-201 infusion

Awards & highlights

Study Summary

This trial tests an experimental drug to see if it is safe and effective for treating patients with myopathy, an inflammation of the muscles.

Who is the study for?

This trial is for adults aged 18-65 with active idiopathic inflammatory myopathy (IIM), including conditions like dermatomyositis and antisynthetase syndrome. Participants must have evidence of ongoing disease despite treatment, shown by muscle weakness or tests like MRI. Excluded are those with severe reactions to the study drugs, active infections needing treatment, major organ issues, previous CAR T cell therapy, or any transplants.Check my eligibility

What is being tested?

The trial is testing CABA-201 after patients receive fludarabine and cyclophosphamide preconditioning. It's an open-label study which means everyone knows they're getting the experimental treatment and there's no placebo group.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as fever and fatigue, complications from leukapheresis (a procedure to collect white blood cells), and risks associated with chemotherapy agents used in preconditioning like nausea and low blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience muscle weakness.

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I am between 18 and 65 years old.

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My condition is active despite treatment, shown by tests like MRI or high CK levels.

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I have been diagnosed with a muscle condition due to specific antibodies in my blood.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 28 days after caba-201 infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 28 days after caba-201 infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days after caba-201 infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate adverse events reported by subjects

Secondary outcome measures

To characterize the pharmacodynamics (PD)

To characterize the pharmacokinetics (PK)

To evaluate adverse events and laboratory abnormalities

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: CABA-201Experimental Treatment1 Intervention

DM Cohort: Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide preconditioning in subjects with DM ASyS Cohort: Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide preconditioning in subjects with ASyS IMNM Cohort: Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide preconditioning in subjects with IMNM

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cabaletta BioLead Sponsor

5 Previous Clinical Trials

99 Total Patients Enrolled

Medical DirectorStudy ChairCabaletta Bio

2,777 Previous Clinical Trials

8,064,386 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the prerequisites to enroll in this research endeavor?

"Qualified individuals for this clinical research must have a diagnosis of inflammatory myopathies and be between 18-65 years old. As of now, the trial plans to enrol approximately eighteen volunteers."

Answered by AI

Is this experiment currently in the process of recruiting participants?

"This clinical trial, which first appeared on November 17th 2023 and was last updated a fortnight later, is currently recruiting participants."

Answered by AI

Is the participant age range for this trial inclusive of those over 20 years old?

"We are welcoming applicants who have attained the age of consent and are under 65 years old to participate in this study."

Answered by AI

What is the scope of this trial regarding patient participants?

"Affirmative. According to information on clinicaltrials.gov, this medical investigation is currently enrolling participants with the first post dating back to November 17th 2023 and the most recent update being made on November 30th 2023. 18 individuals are needed at a single location for enrolment in the trial.."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy

2023. "RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06154252.

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